A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Seagen

Status and phase: Completed; Phase 1

Conditions: Burkitt Lymphoma; Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Treatments: Drug: SGN-CD19A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01786096

SGN19A-001

Details and patient eligibility

About

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

Enrollment: 92 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
• Eastern Cooperative Oncology Group status of 2 or lower
• Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
• Measurable disease

Exclusion criteria

• Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

SGN-CD19A

Experimental group

Description:

SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

Treatment:

Drug: SGN-CD19A